Phase
Condition
In Vitro Fertilization
Treatment
Ubiquinol 100 MG Oral Capsule
Ubiquinone 200 Mg Oral Capsule
Clinical Study ID
Ages 37-43 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Women age >37 and <43 years undergoing their first in vitro fertilization (IVF)cycle
Day 3 follicle-stimulating hormone (FSH) <12 IU/L with serum estradiol <250 pmol/Land normal thyroid-stimulating hormone (TSH) and Prolactin
Partner with semen analysis suitable for IVF or ICSI
Anti-müllerian hormone (AMH) > 3 pmol/L
Be willing and able to provide written informed consent for the study.
Be an otherwise healthy female and considered eligible by the investigator to betreated with a daily dose of 225 IU Recombinant human FSH (recFSH) and 75 IU Humanmenopausal gonadotrophins (hMG).
Documented history of infertility for at least 12 months before randomization (notapplicable in case of tubal infertility or severe male factor infertility, or whenthe use of donor sperm is indicated)
Have a body mass index (BMI) ≥17.5 and ≤38 kg/m2
Have available ejaculatory sperm (use of donated and/or cryopreserved sperm isallowed)
Have a normal uterine cavity (no evidence of uterine polyp or submucosal fibroid) asassessed by either saline-infused sonohysterography or by hysteroscopy within 12months of randomization
Have results of clinical laboratory tests (hematology, serum chemistry, andurinalysis) within normal limits or clinically acceptable to the investigator
Has a pelvic ultrasound showing no cyst ≥15 mm
Exclusion
Exclusion Criteria:
Has been diagnosed with or treated for any endocrine abnormality within 3 yearsprior Note: Participants with a history of clinical or subclinical hypothyroidismmay be eligible if thyroid stimulating hormone levels at screening are within normallimits and the participant has been on a stable dose of thyroid replacementmedication (or on no replacement therapy) for at least 8 weeks.
Has a prolactin level above the upper limit of normal for the central laboratory
Has FSH >12.0 IU/L
Has a history of a full or partial resection of an ovary, including a history ofovarian cystectomy, or of any ovarian tumors limiting access to the ovary duringovum pick-up, e.g., endometriomas or teratomas measuring >10 mm
Has unilateral or bilateral hydrosalpinx that communicates with the endometrialcavity on screening ultrasound or hysterosalpingography.
Has intramural fibroids ≥3 cm or submucosal fibroids of any size
Has Asherman's syndrome (untreated) or endometrial polyps that have not beenresected
Has any congenital uterine abnormality which is associated with a decreased chanceof pregnancy
Inadequate visualization of 1 or both ovaries
One or both ovaries not accessible for oocyte retrieval
Has a history of recurrent pregnancy losses (i.e., >3 pregnancy losses)
Has a history or current evidence of human immunodeficiency virus (HIV) Note:Results obtained within 1 year prior to signing the informed consent form areconsidered valid.
Has tumors of the ovary, breast, uterus, pituitary, or hypothalamus
Has a history of epilepsy, thrombophilia, diabetes, untreated or inadequatelytreated subclinical hypothyroidism, clinically significant cardiovascular,gastrointestinal, hepatic, renal, pulmonary, or auto-immune disease requiringtreatment within the last 3 years
Is a current smoker who smokes ≥5 cigarettes per day
Is assessed by the Investigator as unlikely or unable to adhere to dose and/or visitschedules
Study Design
Study Description
Connect with a study center
Trio Fertility
Toronto, Ontario M5G 2K4
CanadaActive - Recruiting
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